Intragastric space filler

ABSTRACT

A gastric space filler device for treating obesity in a patient by reducing the stomach volume comprising an inflatable space filler and a safety element secured to the space filler, wherein the safety element yields a noticeable signal for causing removal of the space filler.

FIELD OF THE INVENTION

The present invention is generally related to implantable weight controldevices. More particularly, the present invention is related to anintragastric space filler device which is retrievably implantable in apatient.

BACKGROUND OF THE INVENTION

Gastric space fillers used for achieving loss of weight in extremelyobese persons have been known in the prior art. All gastric spacefillers utilized for this purpose function on the principle that anempty bag or space filler is placed into the stomach through theesophagus. Thereafter, the bag or space filler is filled (fully orpartially) with a suitable insufflation fluid, such as saline solution,through a filler tube or catheter which is inserted into the stomachthrough the mouth or the nose. The space filler occupies space in thestomach thereby leaving less room available for food and creating afeeling of satiety for the obese person. Clinical experience of theprior art has shown that for many obese patients the intragastric spacefillers significantly help to control appetite and accomplish weightloss. Among the intragastric bags or space fillers described in theprior art, one type remains connected to a filler tube during the entiretime period while the space filler is in the stomach. The tube isintroduced into the patient's stomach through the nostrils. Such anintragastric space filler is described, for example, in U.S. Pat. No.4,133,315.

Garren et al. in U.S. Pat. No. 4,416,267 and 4,899,747, entire contentsof which are incorporated herein by reference, discloses a stomachinsert for treating obesity in humans by reducing the stomach volumecomprising a flexible torus-shaped inflatable space filler having acentral opening extending therethrough. At least a portion of the spacefiller has a self-sealing substance to facilitate puncture thereof witha needle for inflating the space filler and sealing off the punctureupon removal of the needle. The method herein comprises positioning thespace filler inside the stomach of the person being treated for obesityso as to reduce the stomach volume. The Garren et al. stomach insertworks satisfactorily to control the appetite. However, the insert maydeflate and collapse unexpectedly resulting in obstructing the pylorusor small intestines. It appears desirable to have a space filler systemthat yields some noticeable warning and prompts timely removal of theimplant from the patient.

Several surgical techniques have been tried which bypass the absorptivesurface of the small intestine or aim at reducing the stomach size byeither partition or bypass. These procedures have been proven bothhazardous to perform in morbidly obese patients and have been fraughtwith numerous life-threatening postoperative complications. Moreover,such operative procedures are often difficult to reverse.

Non-surgical approaches for the treatment of obesity include voluntarydieting which is often unsuccessful since most persons do not possesssufficient willpower to limit the intake of food. Other approachesinclude the use of stomach fillers such as methylcellulose, often takenin the form of tablets. The methylcellulose expands in the stomachleaving the person with a filled-up feeling. Also, inflatable bag andtube combinations have been proposed wherein the bag is swallowed intothe stomach and the tube attached thereto is used to periodicallyinflate the bag, particularly just prior to mealtime or during the meal.Once the person has eaten, the bag can be deflated all at once, or itcan be deflated gradually over a period of a few hours so as to simulatethe condition of digestion occurring and the gradual reduction ofstomach contents.

U.S. Pat. No. 4,133,315 issued on Jan. 9, 1979, entire contents of whichare incorporated herein by reference, discloses such an inflatable bagand tube combination. The tubing remains attached to the bag and insidethe esophagus of the person being treated. These tubes are often thecause of erosions and ulcerations of the esophagus. This patent alsodiscloses a gastrotomy method wherein the permanently attached tube usedto distend the stomach bag extends through an opening in the stomachwall as well as an opening in the abdomen.

U.S. Pat. No. 4,246,893 issued on Jan. 27, 1981, entire contents ofwhich are incorporated herein by reference, discloses an inflatable bagand tube combination which is surgically positioned outside and adjacentto the stomach. Upon inflation of the bag, the upper abdomen isdistended and the stomach compressed to thereby produce a sense ofsatiety which reduces the person's desire to ingest food.

U.S. Pat. No. 4,598,699 issued on Jul. 8, 1996, entire contents of whichare incorporated herein by reference, discloses an endoscopic instrumentfor removing an inflated insert from the stomach cavity of a personbeing treated for obesity comprising an elongated flexible tube havingpassageways therein and a holding device at the distal end of theflexible tube that is constructed and arranged to grasp and stabilizethe inflated stomach insert.

Certain prior art discloses a gastric stimulator apparatus forstimulating neuromuscular tissue in the stomach, for example, U.S. Pat.No. 6,826,428. In one disclosure, it provides a method of regulatinggastrointestinal action using a stimulatory electrode and a sensor toprovide retrograde feedback control of electrical stimulation to the GItract or to the stomach.

U.S. Pat. No. 4,694,827 issued on Sep. 22, 1987, entire contents ofwhich are incorporated herein by reference, discloses a ballooninsertable and inflatable in the stomach to deter ingestion of food andhaving, when inflated, a plurality of smooth-surfaced convex protrusionsdisposed to permit engagement of the stomach wall by the balloon only atspaced localities, for minimizing mechanical trauma of the stomach wallby the balloon.

U.S. Pat. No. 6,746,460 issued on Jun. 8, 2004, entire contents of whichare incorporated herein by reference, discloses an expandable devicethat is inserted into the stomach of the patient that is maintainedwithin by anchoring or otherwise fixing the expandable device to thestomach walls. Such expandable devices have tethering regions forattachment to the one or more fasteners which can be configured toextend at least partially through one or several folds of the patient'sstomach wall. Such fasteners can be formed in a variety ofconfigurations, e.g., helical, elongate, ring, clamp, and they can beconfigured to be non-piercing.

Hence, reducing the size of the gastric compartment has been shown toinduce weight loss in a significant percentage of people, and thepresent invention is aimed at a device which non-operatively reduces thesize of the gastric compartment and which is easily removed. One aspectof the invention discloses a gastric space filler device with programmedvolume-adjustable capability or warning signals for device potentialfailure.

SUMMARY OF THE INVENTION

In accordance with preferred embodiments of the present invention, someaspects of the invention relate to a gastric space filler system fortreating obesity in a patient by reducing the stomach volume comprisingat least two flexible inflatable space fillers secured to each other, afirst space filler being inflatable to a volume inside the stomach andnot in fluid communication with the other remaining space fillers,wherein at least a portion of the first space filler is made of abiodegradable material. In one embodiment, the gastric space fillerdevice of the present invention is characterized with little or minimaleffects of bowel obstruction, erosion, perforation and infection to apatient. In one preferred embodiment, the space filler generallyapproximates the shape of the stomach and accomplishes more completespace filling (up to 95% of stomach volume).

In one embodiment, the space filler system comprises pressure readingmeans for transmitting internal pressure readings of one space filler toa receiver or controller. In a further embodiment, a pressure sensorelement is mounted on a first of the at least two space fillers of thegastric space filler system for sensing an internal pressure of thefirst space filler. In a further embodiment, the pressure sensor elementfurther comprises a transmitter for wirelessly transmitting the measuredinternal pressure signal to a receiver outside a body of the patient.The measured internal pressure is compared to a pre-determined thresholdpressure for signaling removal of the filler system. In some embodiment,the pressure sensor element may be substituted by a pH sensor, aflow-rate sensor, a temperature sensor, an electrolyte sensor, or thelike.

In some embodiment, two of the at least two space fillers of the gastricspace filler system are configured to be in tandem inside the stomachpouch or are configured to be substantially parallel to each other.

In one embodiment, at least one of the two space fillers of the gastricspace filler system is anchored to an inner wall of the stomach. In afurther embodiment, the anchoring action is arranged and configured toactivate the anchoring mechanism when the space filler is inflated whilecontacting the inner wall of the stomach, and to reverse the anchoringmechanism when the filler is deflated.

In a further embodiment, at least a portion of the at least two spacefillers is ultrasonically visible. One method of visualization is tohave ultrasonically visible air bubble at or on part of the spacefiller. Another method is to incorporate ultrasonically visible contrastagent at or on part of the space filler.

In one embodiment, the gastric space filler device is configured to bedeliverable through an esophagus of the patient. In another embodiment,at least a portion of an external surface of the space filler is treatedwith an anti-acid substance, corrosion-resistant substance oranti-adhesion substance, wherein the substance comprisespolytetrafluoroethylene, inert material, or other biological material(such as albumin, melatonin, phosphorylcholine, or protein) that arebiocompatible. Methods of treating the surface include coating,painting, dipping, impregnation, and the like.

Some aspects of the invention provide a gastric space filler device fortreating obesity in a patient by reducing the stomach volume comprisingan inflatable space filler and a safety element secured to the spacefiller, wherein the safety element comprises a mechanism to yield anoticeable signal for causing a removal of the space filler.

Some aspects of the invention provide a gastric space filler device fortreating obesity in a patient by reducing a stomach volume comprising aninflatable space filler with a first reference shape at an inflatedstate and means for substantially maintaining the first reference shapeat a deflated state. In one embodiment, the means for substantiallymaintaining the first reference shape at the deflated state is toprovide a spiral supportive ridgeline onto the space filler, wherein thespiral ridgeline may comprise a material similar to material of thespace filler. In another embodiment, the means for substantiallymaintaining the first reference shape at the deflated state is toprovide a plurality of cross bars inside an interior space of the spacefiller.

Some aspects of the invention provide a gastric space filler device fortreating obesity in a patient by reducing a stomach volume comprising aninflatable space filler with a first cross-sectional circumferencedimension at an inflated state and means for maintaining a secondcross-sectional circumference dimension with at least 75 percentage ofthe first circumference dimension at a deflated state.

In one embodiment, any of the at least two space fillers of the gastricspace filler system has a central opening extending therethrough. Inanother embodiment, one of the at least two space fillers is fabricatedfrom polyurethane sheet material. In still another embodiment, thepolyurethane sheet material comprises a single layer. Other polymersheet material, compliant (for example, silicone or Nylon) ornon-compliant (for example, polyethylene or polytetrafluoroethylene),may also be suitable for the intended purposes.

In one embodiment, the biodegradable material for the gastric spacefiller system is selected from a group consisting of polymers orcopolymers of lactide, glycolide, caprolactone, polydioxanone,trimethylene carbonate, polyorthoesters and polyethylene oxide. Inanother embodiment, one of the at least two space fillers is made of anon-biodegradable material selected from a group consisting ofpolyester, polypropylene, Nylon, polyethylene, co-polymers thereof, andthe like.

Some aspects of the invention relate to a method of treating obesity ina patient comprising the steps of: providing a deflated gastric spacefiller system with an infusing tube releasably attached thereto insidean elongate catheter sheath, wherein the space filler system comprisesat least two flexible inflatable space fillers secured to each other, afirst space filler being inflatable to a volume inside the stomach andnot in fluid communication with the remaining space fillers, wherein atleast a portion of the first space filler is made of a biodegradablematerial; introducing the catheter sheath through the mouth and into thestomach; urging the gastric space filler system out of the cathetersheath and into the stomach; inflating each space filler through theinfusing tube with a given amount of fluid to increase the volumethereof; and removing the infusing tube from the stomach and out throughthe mouth.

In one embodiment, the inflating step comprises inflating at least oneof the space fillers to a pressure slightly higher than a stomachpressure of the patient, preferably to a pressure difference of at least1 mm Hg above a stomach pressure of the patient. In one embodiment, themethod further includes a step of detecting a deflated space filler thattriggers the step of removing the gastric space filler device.

In one embodiment, the method for removing the gastric space fillersystem from the stomach is by introducing extraction means through themouth and into the stomach, grasping and puncturing all of the at leasttwo space fillers with the extraction means, and then withdrawing thedeflated gastric space filler out of the stomach and through the mouth.In one embodiment, the extraction means includes a fiberopticgastroscope with needle biopsy forceps.

In one embodiment, the method for removing the gastric space fillersystem from the stomach is by radially shrinking all of the at least twospace fillers to fit inside a lumen of the extraction catheter sheath,and then withdrawing the deflated gastric space filler system out of thestomach and through the mouth.

In a further embodiment, the method further includes a step of detectingan internal pressure of at least one space filler prior to the step ofremoving the gastric space filler device.

Some aspects of the invention provide a method of treating obesity in apatient comprising the steps of: providing an inflatable gastric spacefiller device, wherein the device comprises a first space filler and asecond space filler enclosed within the first space filler, the devicecomprising a safety mechanism to yield a noticeable signal for causing aremoval of the device; introducing the device through the mouth and intothe stomach; and removing the device once the noticeable signal isreceived.

Some aspects of the invention provide a method of treating obesity in apatient with minimal nausea effects comprising implanting a stomachspace filler device coated with an anti-nausea agent.

Some aspects of the invention provide a method of treating obesity in apatient comprising the steps of: a) providing a deflated gastric spacefiller device with an infusing tube releasably attached thereto insidean elongate catheter sheath, wherein the space filler device comprisesan inflatable space filler and a safety mechanism secured to the spacefiller, wherein the safety mechanism yields a noticeable signal forcausing a removal of the space filler; b) introducing the cathetersheath through the mouth and into the stomach; c) urging the gastricspace filler device out of the catheter sheath and into the stomach; d)inflating the space filler through the infusing tube with a given amountof fluid to increase the volume thereof; and e) removing the infusingtube from the stomach and out through the mouth.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional objects and features of the present invention will becomemore apparent and the invention itself will be best understood from thefollowing Detailed Description of Exemplary Embodiments, when read withreference to the accompanying drawings.

FIG. 1 shows a gastric space filler system with two space fillerssecured to and in parallel to each other.

FIG. 2 shows a first space filler of the two space fillers in FIG. 1with a central passageway therethrough.

FIG. 3 shows a gastric space filler system with two space fillerssecured to and in tandem to each other.

FIG. 4 shows a gastric space filler system having an inflatable spacefiller with a support mechanism thereto.

FIG. 5 shows a cross-sectional view of the support mechanism of FIG. 4.

FIG. 6 shows a pressure sensor element mounted on a space filler inaccordance with the principles of the present invention.

FIG. 7 shows a delivery apparatus for non-surgically implanting agastric space filler system.

FIG. 8 shows one embodiment of removing a gastric space filler systemfrom the patient.

FIG. 9 shows one embodiment of a gastric space filler system with twoconnected expandable elements.

FIG. 10 shows an illustration of the gastric space filler system of FIG.9 in a recipient.

FIG. 11 shows one embodiment of an adjustable space filler system.

FIG. 12 shows an alternate embodiment of an adjustable space fillersystem.

FIG. 13 shows a space filler device comprising a shape retentionmechanism.

FIG. 14 shows a perspective view of the space filler device of FIG. 13.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The preferred embodiments of the present invention described belowrelate particularly to an intragastric space filler device comprising atleast one space filler for reducing the stomach volume and one spacefiller made of biodegradable material, wherein the biodegradable spacefiller (that is, at least a portion of the space filler is made ofbiodegradable material) is used as a warning signal for timely removalof the space filler device. While the description sets forth variousembodiment specific details, it will be appreciated that the descriptionis illustrative only and should not be construed in any way as limitingthe invention. Furthermore, various applications of the invention, andmodifications thereto, which may occur to those who are skilled in theart, are also encompassed by the general concepts described below.

The stomach has a lot of functions and one of these is to expand andcontract. This J-shaped organ has very active muscles. These musclesexpand and contract depending on how much food is in the stomach. Thiscontraction is a form of mechanical breakdown of the food. The purposeof this breakdown is to increase the available surface area for thechemicals to act on it. The gastric glands of the stomach secreteenzymes that perform chemical breakdown, partly digesting the proteins.Pepsin is the enzyme that breakdowns protein. The gastric gland alsosecretes hydrochloric acid that kills almost all the bacteria in thefood. It also secretes mucus that protects the stomach wall from thehydrochloric acid. By the time all the food is mechanically andchemically broken down, the food becomes a semi-fluid substance thatleaves the stomach by peristalsis entering the small intestine.

The structure of the stomach is quite unique. It can be divided intofour subdivisions: the cardia, the fundus, the body, and the pylorus.The cardia is the region that is closest to the heart and is where theesophagus is connected to the stomach. The fundus is the region thatcurves above the rest of the stomach (with respects to a person who isstanding upward). The body of the stomach is the largest region locatedin the center. The pylorus is the region that is connected to the smallintestine. The cardia and the pylorus have sphincter muscles thatregulate the movement of food and fluids. The hydrochloric acid normallydoes not go back up the esophagus. When one vomits and has a burningsensation in the esophagus, it is the hydrochloric acid from thestomach.

The volume of the human stomach varies depending on the person.Generally, human stomachs have a volume about one liter. Since thestomach has the ability to expand, it can hold much more food. The humanstomach can be distended up to four liters, which is more than onegallon. Imagine your stomach to be an empty one-gallon milk carton.There is plenty room for food.

Double Space Filler System

FIGS. 1-14 show one or alternate embodiment of a gastric space fillerdevice and delivery means for implanting and retrieving the gastricspace filler device of the present invention. FIG. 1 shows a stomachbubble or space filler system 19A with two space fillers 21A, 21Bsecured to and in parallel to each other, whereas FIG. 3 shows a gastricspace filler system 19B with two space fillers 22A, 22B secured to andin tandem to each other. Both space fillers of the gastric space fillersystem are deflated, collapsed and retracted within a catheter sheath 25during the delivery phase or the retrieval phase of the device.

In a preferred embodiment, the gastric space filler system comprises twospace fillers, wherein the second space filler is enclosed within thefirst space filler, wherein at least a portion of the first space filleris made of a biodegradable material and/or with a pressure sensorelement for measuring the pressure of the first space filler. In afurther embodiment, the gastric space filler system comprises two spacefillers, wherein the second space filler is enclosed within the firstspace filler, wherein at least a portion of the first space filler ismade of a biodegradable material and with a sensor element for measuringthe property of the content of the first space filler, wherein theproperty includes pH, temperature, electrolyte type, electrolyteconcentration, and the like. In another embodiment, the space betweenthe first space filler and the second space filler is filled with afluid or saline plus a dye or odor for earlier detection, when the firstspace filler is compromised, deflated, or leaked.

In one embodiment, the inner surface and/or the outer surface of thedelivery catheter sheath is treated to be hydrophilic or to have reducedsurface friction. The space filler system 19A has a sealed inlet 20 thatallows fluid or saline to be infused into the space fillers via aninfusing tubing 23 or a needle with an infusing tubing which isconnected to an external fluid source. In one embodiment, the sealedinlet has a self-sealing substance to facilitate puncture thereof with aneedle for inflating the space filler and sealing off the puncture uponremoval of the needle. In another embodiment, the sealed inlet isequipped with a one-way check valve for receiving infusing fluid orsaline.

The catheter sheath 25 or delivery device for the gastric space fillersystem passes through the esophagus 24 and cardiac notch 42 into thestomach 40 of a patient. Once it is delivered to the stomach, the spacefillers are inflated. In one embodiment, at least one of the spacefillers is a non-compliant one that is inflated to a pressure slightlyhigher than the local atmospheric pressure or stomach pressure,preferably a pressure difference of about 1-20 mm Hg, more preferablyabout 1-5 mm Hg. One rationale of a higher pressure for the space filleris to maintain the desired occupied space volume, though the internalpressure might drift a fraction of the mm Hg pressure over the course ofimplantation. In some aspects of the invention, the gastric space fillerdevice 19A comprises a plurality of connecting members 26A, 26B betweenthe second space filler 21B and the first space filler 21A that isconnected to the infusing tubing 23 via the sealed inlet.

In one embodiment, the connecting members are made of flexible and/orelastic material. In another embodiment, the connecting members are madeof solid material that allows no fluid communication between the twospace fillers. In one embodiment, a plunger is used to push the spacefiller device out of the lumen of the delivery device. In an alternateembodiment, the plunger of the delivery means comprises aforward-pulling mechanism at the very distal end distal to the spacefiller device. During the delivery phase, the space filler device isunder axial tension (i.e., under some pulling force between the distalend and the proximal end of the flexible space filler) to cause minimalcircumferential profile for easy insertion into the sheath.

FIG. 2 shows a first space filler 21A of the two space fillers in FIG. 1with a central passageway 33 therethrough. In one embodiment, thegastric space filler comprises a plurality of passageways therethrough,wherein some passageways are connected to one another. In oneembodiment, at least one connecting member 26A comprises a one-way checkvalve or seal enabling the fluid to flow from the first space filler 21Ainto the second space filler 21B, but preventing fluid from returningback to the first space filler 21A. In some aspects of the invention asshown in FIG. 3, the gastric space filler device 19B comprises aplurality of connecting members 36 between the second space filler 22Band the first space filler 22A, wherein the first space filler isconnected to the infusing tubing via the sealed inlet.

Some aspects of the invention provide a gastric space filler system fortreating obesity in a patient by reducing the stomach volume comprisingat least two flexible inflatable space fillers secured to each other,each space filler being inflatable to a volume inside the stomach and afirst space filler 21A is in one-way fluid communication with theremaining other space fillers 21B, wherein at least a portion of thefirst space filler 21A is made of a biodegradable material. In oneembodiment, a check valve permits the flow of fluid in only onedirection from the first biodegradable space filler through a conduit tothe second space filler.

In one embodiment, the biodegradable portion of the biodegradable spacefiller is sized and configured to biodegrade at a specified timeduration, the biodegradation of the biodegradable space filler and itssubsequent deflation serving as a warning signal for retrieving thewhole gastric space filler device. There provides a safety feature whenthe pressure sensor on the biodegradable space filler emits alow-pressure signal as a result of space filler deflation. Some aspectsof the invention provide a warning window (that is, a time period) toremove or retrieve the gastric space filler system when one space filleris deflated or signaled with low pressure. This would prevent thecatastrophic or life-threatening blocking/obstructing of the pylorus 42by a completely (all space fillers in this case) deflated space fillersystem. In one embodiment, the gastric space filler device might beretrieved at a predetermined post-implantation time, for example at 6months post-implantation.

FIG. 4 shows a gastric space filler system 19C with an inflatable spacefiller 27 and a plurality of radially expanded support elements 28thereon, wherein each support element comprises a space filler contactportion 29B and a suspended non-space filler contact portion 29A. Theradially expanded support elements may be secured to each other via acrossing bar 31 or other connecting mechanisms. In one embodiment, theradially expanded support element is sized and configured to stabilizethe space filler inside the stomach by distension against the stomachwall.

FIG. 5 shows a cross-sectional view of one support element of FIG. 4. Inone embodiment, the support element 29 comprises a meshed stentingstructure 38 wrapped or enclosed with biocompatible elastomeric material39, such as silicone, polyurethane, latex, and the like. In oneembodiment, the elastomeric material comprises a high percentage ofvoids or micropores, like a sponge or foam. In one embodiment, themeshed stenting structure is similar to a cardiovascular stent that iseither self-expandable or balloon expandable. In one embodiment, themeshed stenting structure is mechanically crimpable or may be made oftemperature sensitive shape memory Nitinol.

One mechanism of mechanically crimping the meshed stenting structure isillustrated in FIG. 11. In a first step of operations, the supportelement is arranged and configured to be crimped circumferentially orradially inwardly to a smaller profile, together with the deflated spacefiller, configured to be retracted into the delivery catheter sheath. Ina second step of operations, the support element self-expands afterreleasing the constraint thereon from the catheter sheath, along withthe inflated space filler, to occupy an appropriate space inside thestomach 40. In a third step of operations during the retrieval phase, aretriever instrument with certain crimping capability is advanced intothe stomach to orient the support element and to crimp the element to asmall profile configured to be retracted within the lumen of theretriever instrument (for example, a retrieving catheter sheath). Thedeflated space filler, and together with the crimped supportingelements, are withdrawn from the stomach to outside the body of thepatient.

At about the middle section of the meshed stenting device 38circumferentially, there provide some crossing points of any two meshstruts. As illustrated in FIG. 8, a tether 55 extends through a frontside and a backside of each crossing point alternately. The tether isthen joined in a loop with one end of the tether extending through aloop 56 in the other end of the tether and extending slightly out of theplane with an end loop 57. At a retrieval time, the end loop 57 issnatched or grasped by a retriever apparatus (such as the apparatushaving a hook, a grasper, or the like) and pulled toward outside of themouth, enabling collapsing circumferentially the stenting structure to amuch smaller profile for removal out of the body.

The device of the present invention intends to provide mechanisms forpreventing or avoiding migration, bowel obstruction, bleeding diathesis,erosion, perforation of stomach or any internal organs, and the like.Some complications are acceptable if the benefits of device design faroutweigh the risks, such as access site related minor complications,some patient discomfort due to the presence of the device or due toaccess site related issues, nausea, feeling of bloating, and the like.

U.S. Pat. No. 6,890,300, entire contents of which are incorporatedherein by reference, discloses a MEMS (microelectrical mechanicalsystems) chip sensor based upon detection of an induced inductance inthe sensor. The sensor is used in an environment for detection of fluidpressure. The method and system is particularly useful in humans tosense pressure changes.

U.S. Pat. No. 6,939,299, entire contents of which are incorporatedherein by reference, discloses an implantable miniaturized pressuresensor integrates a capacitor and an inductor in one small chip, whereinthe capacitor has an upper capacitor plate and a lower capacitor plateconnected to one or more spiral inductor coils. The sensor ismicromachined from silicon to form a thin and robust membrane disposedon top of the upper capacitor plate to sense an external fluid pressure.The resonant frequency of the sensor can be remotely monitored andcontinuously measured with an external detector pick up coil disposedproximate the sensor.

Some aspects of the invention provides a method for determining fluidpressure within a patient or within a space filler comprising: (a)providing a wireless capacitive MEMS chip sensor comprising aninductance coil and spaced apart capacitor plates as aninductive-capacitive circuit, with the fluid in pressure contact withone of the capacitive plates; (b) inducing a mutual inductance as anexternal signal into the sensor to produce the resonant frequencyresponse as an internal signal from the sensor; and (c) determining thefluid pressure within the patient externally of the patient from theinternal signal as a function of the resonant frequency response fromthe sensor resulting from a change in capacitance of the sensor due to avariation in the spacing of the plates produced by the fluid pressure ofthe fluid from the sensor resulting from the change in the seriesresistance. A pressure sensor element and methods of use are well knownto one skilled in the art, for example the MEMS unit disclosed in U.S.Pat. No. 6,890,300 or U.S. Pat. No. 6,939,299.

Space Filler with Safety Features

FIG. 6 shows a pressure sensor element 51 (which may be similar to theone disclosed in U.S. Pat. No. 6,890,300) mounted on a space filler 21Ain accordance with the principles of the present invention. In oneembodiment, a gastric space filler device 19D comprises a recess area 50sized and configured to appropriately receive and mount a pressuresensor element 51. The sensor element 51 comprises an opening 52 inpressure communication with an internal void 53 of the space fillerdevice 19D.

Some aspects of the invention provide a pressure sensor element to bemounted on a first of the at least two space fillers of the gastricspace filler system for sensing an internal pressure of the first spacefiller. In one embodiment, the pressure sensor element is mounted on thebiodegradable space filler of the gastric space filler system. Inanother embodiment, a pressure sensor element is mounted on any or allof the at least two space fillers of the present invention. In a furtherembodiment, the pressure sensor element further comprises a transmitterfor wirelessly transmitting the measured internal pressure to a receiveroutside a body of the patient or recipient.

FIG. 7 shows a standard catheter sheath for deploying a gastric spacefiller device to a patient, wherein the gastric space filler devicecomprises at least two space fillers 22A and 22B connected by means ofconnecting members 36. In one embodiment, after advancing the cathetersheath into about the stomach, the infusing tubing 23 serves as apushing plunger for pushing the gastric space filler device into thestomach of the patient. Thereafter, the space fillers are filled withsaline or fluid via the infusing tubing from an external fluid/salinesource. Some aspects of the invention provide a method of treatingobesity in a patient comprising the steps of. (A) providing aninflatable gastric space filler system with an infusing tube releasablyattached thereto inside an elongate catheter sheath, wherein the spacefiller system comprises at least two flexible inflatable space fillerssecured to each other, a first space filler being inflatable to a volumeinside the stomach and not in fluid communication with the remaining oneor other space fillers, wherein at least a portion of the first spacefiller is made of a biodegradable material; (B) introducing the cathetersheath through the mouth and into the stomach; (C) urging the gastricspace filler system out of the catheter sheath and into the stomach; (D)inflating each space filler through the infusing tube with a givenamount of fluid to increase the volume thereof; and (E) removing theinfusing tube from the stomach and out through the mouth.

In one embodiment as illustrated in FIG. 2, a gastric space fillerdevice 19B for treating obesity in a patient by reducing the stomachvolume comprising a flexible inflatable space filler 22A and a safetyelement 22C secured to the space filler 22A, wherein the safety elementyields a noticeable signal for causing removal of the space fillerdevice. In one embodiment, the safety element is a visible dye so that,when the space filler is compromised, visible dye appears in urineshortly. In one embodiment, the safety element is a special odor sothat, when the space filler is compromised or leaked, smellable odorappears in urine shortly. In a further embodiment, the safety elementcomprises biodegradable material so that when the safety elementbiodegrades prematurely, it yields a signal for prompt removal, such asthe decomposed/biodegraded pieces.

The safety element may comprise means for maintaining “appropriate shaperetention” of the space filler so the compromised space filler (eithervia leaking or collapsing) does not cause bowel obstruction. The“appropriate shape retention” is herein to mean that the residualcross-sectional shape or circumference dimension after filler compromisemaintains a value not to cause bowel obstruction. In one embodiment, theappropriate dimension retention is at least 50%, preferably 75%, of thepre-compromised reference value.

Some aspects of the invention provide a gastric space filler device fortreating obesity in a patient by reducing the stomach volume comprisingan inflatable space filler with a reference shape and means forsubstantially maintaining the reference shape after the space filler isdeflated by accident or intentionally. For illustration purposes, themeans for maintaining the reference shape of the space filler is toincorporate a relatively rigid supportive spiral ridgeline along theinterior surface of the space filler. By way of illustration, thesupportive ridgeline is similar to the reinforcing spiral elements alongan internal surface of a hose. The ridgeline is sized (at least onecomplete hoop circle) and configured to resist compressive pressure fromthe stomach wall, but is flexible and collapsible by a retrievableinstrument either through clamping, crimping or other mechanicaldestructive methods. In one embodiment, the ridgeline is made of thesame biocompatible material as the space filler. In another embodiment,the ridgeline is an integral part of the space filler. In still anotherembodiment, the ridgeline contains a wholly enclosed elastic metal wireor coil by the same biocompatible material of the space filler.

For further illustration purposes, the means for maintaining thereference shape of the space filler is to incorporate a plurality ofrelatively rigid cross bars inside the interior space of the spacefiller, wherein each end of the cross bars is secured to the interiorwall of the space filler. The structure of the cross bars is sized andconfigured to resist compressive pressure from the stomach wall, but isflexible and collapsible by a retrievable instrument either throughclamping, crimping or other mechanical destructive methods. In oneembodiment, the cross bar is made of the same biocompatible material asthe space filler. For further illustration purposes, the means formaintaining the reference shape of the space filler is to incorporate afoam material inside the interior volume of the space filler. Thestructure of the foam material is sized and shaped to resist compressivepressure from the stomach wall, but is flexible and collapsible by aretrievable instrument either through clamping, crimping, drawing stringtechnique (as shown in FIG. 11) or other mechanical methods. Bymaintaining the shape of the space filler substantially similar to thereference shape after the space filler is deflated by accident orintentionally would cause the space filler remain inside the stomach andnot to obstruct the bowel.

FIGS. 13 and 14 show an intragastric space filler 71 with a shaperetention mechanism made of different material as compared to theinflatable filler material. In one preferred embodiment, the spacefiller comprises two torus 73, 74. In another embodiment, the firsttorus space filler 73 and the second torus space filler 74 become oneoverall balloon-like space filler wrapped over the shape retentionmechanism 72 and connected by the balloon-enclosed middle section 77. Asshown in FIG. 14, the shape retention mechanism further comprises aspring-like coil 75 that is semi-compressible configured to resistcompressive pressure from the stomach wall, but is flexible andcollapsible by a retrievable instrument either through clamping,crimping, drawing string technique (as shown in FIG. 11) or othermechanical destructive methods. The shape retention mechanism may bemade of Nitinol or other resilient, flexible metal or polymer.

A balloon-like space filler is generally manufactured by dip coating amandrel into silicone solution a few times to build up the thickness.For connecting a balloon-like space filler with another space filler orsafety element, silicone compatible adhesive is generally used, forexample, RTV silicone or moderate temperature curing silicone adhesive.

In some embodiment, the safety element 22C comprises a pressure sensorelement for sensing an internal pressure of the space filler 22A,wherein the pressure sensor element may further comprise a transmitterfor wirelessly transmitting a measured internal pressure to a receiveroutside a body of the patient. In one embodiment, the safety elementcomprises a pH sensor element for sensing a pH of a stomach of thepatient, wherein the pH sensor element may further comprise atransmitter for wirelessly transmitting the sensed pH to a receiveroutside a body of the patient. The sensed pH or the change of the sensedpH with respect to time is compared to the historic data orpre-determined data for assessing the device performance. If the sensedpH is below the threshold number for a predetermined period, this signalmay prompt retrieval of the space filler device by a practitioner.

In one embodiment, the space filler and the safety element of the spacefiller device are configured to be in tandem inside a stomach pouch. Inanother embodiment, the space filler and the safety element areconfigured to be substantially parallel to each other. In a furtherembodiment, the safety element is anchored to or anchored through aninner wall of a stomach pouch.

In one embodiment, either the safety element or the space filler of thespace filler device is ultrasonically visible. In another embodiment, anultrasonic transducer is mounted on either the safety element or thespace filler for emitting an ultrasonic signal.

In one embodiment, the gastric space filler device is configured to bedeliverable through an esophagus of the patient. In another embodiment,at least a portion of an external surface of the space filler device istreated with an anti-acid substance, or an anti-adhesion substance. In afurther embodiment, the space filler device has a central openingextending therethrough or the space filler is sized to occupy at least90% of a stomach volume of the patient. In a further embodiment, thespace filler has an adjustable volume and is sized and configured tooccupy up to 90% of a stomach volume, preferably 95%, of the patient.The space filler should be able to be increased in size over timethrough port infusion or re-docking infusion. The size of the spacefiller can be adjusted over time to allow initial acceptance by thestomach and increased volume to get the right balance of weight loss andthe lack of nausea and vomiting.

In one embodiment, the space filler device is fabricated frompolyurethane sheet material, wherein the polyurethane sheet materialcomprises a single layer. In another embodiment, the space filler ismade of a non-biodegradable material selected from a group consisting ofpolyester, polypropylene, Nylon, polyethylene, silicone, latex,polyethylene, and copolymers thereof. In one embodiment, the spacefiller device of the present invention is a permanent implant. Inanother embodiment, the space filler device of the present invention hasa useful life of about 3 to 12 months.

In another embodiment, the safety element is an inflatable balloon madeof a biodegradable material, wherein the biodegradable material isselected from a group consisting of polymers or copolymers of lactide,glycolide, caprolactone, polydioxanone, trimethylene carbonate,polyorthoesters, and polyethylene oxide. In another embodiment, thesafety element is an inflatable balloon comprising a biodegradablematerial, wherein the biodegradable material is selected from a groupconsisting of collagen, chitosan, elastin, gelatin, and combinationsthereof.

FIG. 9 shows one embodiment of a gastric space filler device or system19E with two connected expandable elements 48, 49 whereas FIG. 10 showsan illustration of the gastric space filler device of FIG. 9 in thestomach of a patient. The first expandable element 48 is connected tothe second expandable element 49 with a plurality of connecting members47. In one embodiment, the first expandable element 48 and the secondexpandable element 49 is not in fluid communication. In anotherembodiment, at least one of the connecting members 47 has a lumentherethrough for fluid communication between the two elements 48 and 49.Further, at least one of the expandable elements has a centralpassageway 45 for food pass-through.

The gastric space filler device 19E is sized and configured to fit thestomach volume up to 90% (preferably 95%) of the available stomachvolume. In one embodiment, the peripheral surface 44A of the firstelement 48 and/or the peripheral surface 44B of the second element 49 isshaped like a corrugated shape so as to contact the inner wall of thestomach 40 at certain discrete lines (one dimension) of the corrugation,instead of contact areas (two dimensions). In one preferred embodiment,the second expanded element 49 is sized and shaped to distend againstthe inner wall of the stomach 40 at a place spaced away from the pylorussphincter zone 43. In one embodiment, the second expanded element 49comprises a plurality of smooth-surfaced convex protrusions disposed topermit engagement of the stomach wall by the space filler only at spacedlocalities, for minimizing mechanical trauma of the stomach wall by thespace fillers.

Some aspects relate to an anchoring or securing mechanism of the spacefiller that anchors only when the space filler is adequately inflated.In one embodiment, at least one of the two space fillers of the gastricspace filler system is anchored to an inner wall of the stomach. In afurther embodiment, the anchoring action is arranged and configured toactivate the anchoring mechanism (such as from a piercing needle) whenthe space filler is inflated while contacting the inner wall of thestomach, and to reverse the anchoring mechanism when the filler isdeflated. The inflated space filler is maintained within or stabilizedby anchoring or otherwise securing the expandable device to the stomachwalls. In one embodiment, such expandable devices have tethering regionsfor attachment to the one or more fasteners which can be configured toextend at least partially through one or several folds of the patient'sstomach wall. Such fasteners can be formed in a variety ofconfigurations, e.g., helical, elongate, ring, clamp, and they can beconfigured to be non-piercing.

In one embodiment, at least a portion of an external surface of thespace filler is treated with an anti-acid substance, corrosion-resistantsubstance or anti-adhesion substance, wherein the substance comprisespolytetrafluoroethylene, inert material, or other biological material(such as albumin, melatonin, phosphorylcholine, immobilized antibody, orproteins) that are biocompatible. Methods of treating the surfaceinclude coating, painting, dipping, impregnation, and the like. In oneembodiment, the melatonin or PC (phosphorylcholine) coating is on atleast a portion of the outer surface of the space filler. In onepreferred embodiment, the melatonin or phosphorylcholine coating is onat least the portion of the outer surface of the space filler thatintends to contact the stomach wall. The stomach space filler may alsobe made of or surface coated with polyolefin family like high densitypolyethylene, linear low density polyethylene, and ultra high molecularweight polyethylene, fluoropolymer materials like fluorinated ethylenepropylene, polymethylpentene, polysulphons, or some elastomers such asthermoplastic polyurethanes and C-Flex type block copolymers.

Melatonin may reduce the pain associated with irritable bowel syndrome(Gut 2005;54:1402-1407). As is known to one ordinary skill in the art,melatonin is a sleep promoting agent that is involved in the regulationof gastrointestinal motility and sensation. In some prior clinicalexperiment, melatonin was orally administered 3 mg at bedtime for twoweeks, those patients with melatonin regimen show significantattenuation in abdominal pain and reduced sensitivity in rectal pain ascompared to the control group with placebo. Some aspects of theinvention provide a gastric space filler device for treating obesity ina patient by reducing the stomach volume comprising an inflatable spacefiller and a safety element secured to the space filler, wherein thesafety element yields a noticeable signal for causing a removal of thespace filler, wherein at least a portion of an external surface of thespace filler device is treated with melatonin.

PC is found in the inner and outer layers of cell membrane. However, itis the predominant component present in the outer membrane layer, andbecause it carries both a positive and negative charge (zwitterionic),it is electrically neutral. As a result, the outer layer of the cellmembrane does not promote excess adhesion. When PC is coated on orincorporated on a material, protein and cell adhesion is decreased,inflammatory response is lessened, and fibrous capsule formation isminimized. Some aspects of the invention relate to a stomach spacefiller device coated with an immobilized antibody (such as CD34 or thelike) that mimic a biological surface for less adhesion or lessreactive. It is disclosed that a method of treating obesity in a patientwith minimal nausea effects comprising implanting a stomach space fillerdevice coated with an anti-nausea agent, wherein the anti-nausea agentmay be melatonin, albumin or phosphorylcholine to mimic a biologicalsurface.

Adjustable Intragastric Space Filler

The stomach space filler is capable of filling up to 95% of stomach,self-adjustable or portable. It may be dialed or programmed to adjustthe space filler according to input signals of pressure, volume, pH,temperature, size, electrolyte properties, etc. In one embodiment, thespace filler is also equipped with failure detection mechanism, such asbleeding/ulceration detection, migration limiter etc. The adjustablestomach space filler is retrievable. The device may be designed andarranged for restrictive food intake with custom shape that eitheradapts to or is made to the shape and size of a given patient's stomach.

FIG. 11 shows one embodiment of an adjustable space filler system 19Fwhereas FIG. 12 shows an alternate embodiment of an adjustable spacefiller system 19G. In one embodiment, the adjustable space fillercomprises a drawstring 60 coupled to the plurality of rings 62, 63, 64that are secured to the space filler 19F or 19G. In one embodiment, therings may be an integral part of the space filler. A distal end-knot 65of the drawstring 60 is sized larger than the opening of the distal ring64. The distal end-knot keeps the distal end of the drawstring snuglytight around the distal ring secured on the space filler. When theproximal section 60A of the drawstring is pulled away from the spacefiller through the proximal ring 62, the space filler becomes smallerradially or spirally. In one embodiment, a conical shaped blocker 61 canpass the ring in a one-way manner. Therefore, the volume of the spacefiller becomes smaller each time a conical shaped blocker passes theproximal ring 62. To make the space filler with less profile, a trough67 may be sized and configured to allow the drawstring 60 and the rings62, 63, 64 not to protrude beyond the outermost external surface of thespace filler 19G (as shown in FIG. 12).

From the foregoing, it should now be appreciated that a gastric spacefiller device comprising at least two space fillers with at least onespace filler is partially biodegradable has been disclosed. While theinvention has been described with reference to a specific embodiment,the description is illustrative of the invention and is not to beconstrued as limiting the invention. Various modifications andapplications may occur to those skilled in the art without departingfrom the true spirit and scope of the invention as described by theappended claims.

1. A gastric space filler device for treating obesity in a patient byreducing the stomach volume comprising an inflatable space filler and asafety element secured to said space filler, wherein the safety elementcomprises a mechanism to yield a noticeable signal for causing a removalof said space filler.
 2. The gastric space filler device of claim 1,wherein the safety element comprises a pressure sensor element forsensing an internal pressure of said inflatable space filler.
 3. Thegastric space filler device of claim 3, wherein the pressure sensorelement further comprises a transmitter for wirelessly transmitting thesensed internal pressure to a receiver outside a body of the patient. 4.The gastric space filler device of claim 1, wherein the safety elementcomprises a pH sensor element for sensing a pH of a stomach of thepatient.
 5. The gastric space filler device of claim 5, wherein the pHsensor element further comprises a transmitter for wirelesslytransmitting the sensed pH to a receiver outside a body of the patient.6. The gastric space filler device of claim 1, wherein the space fillerand the safety element are configured to be in tandem or substantiallyparallel to each other inside a stomach pouch of the patient.
 7. Thegastric space filler device of claim 1, wherein the safety element isanchored to an inner wall of a stomach pouch of the patient.
 8. Thegastric space filler device of claim 1, wherein either the safetyelement or the space filler is ultrasonically visible.
 9. The gastricspace filler device of claim 1, wherein an ultrasonic transducer isprovided for emitting an ultrasonic signal.
 10. The gastric space fillerdevice of claim 1, wherein the gastric space filler is configured to bedeliverable through an esophagus of the patient.
 11. The gastric spacefiller device of claim 1, wherein at least a portion of an externalsurface of the space filler device is treated with an anti-acidsubstance.
 12. The gastric space filler device of claim 1, wherein atleast a portion of an external surface of the space filler device istreated with a corrosion-resistant substance.
 13. The gastric spacefiller device of claim 1, wherein at least a portion of an externalsurface of the space filler device is treated with an anti-adhesionsubstance.
 14. The gastric space filler device of claim 1, wherein atleast a portion of an external surface of the space filler device istreated with albumin or melatonin.
 15. The gastric space filler deviceof claim 1, wherein at least a portion of an external surface of thespace filler device is treated with phosphorylcholine.
 16. The gastricspace filler device of claim 1, wherein the space filler comprises acentral opening extending therethrough.
 17. The gastric space fillerdevice of claim 1, wherein the space filler is sized to occupy at least90% of a stomach volume of the patient.
 18. The gastric space fillerdevice of claim 1, wherein the space filler has an adjustable volume andis sized and configured to occupy up to 90% of a stomach volume of thepatient.
 19. The gastric space filler device of claim 1, wherein thespace filler comprises a volume-adjusting mechanism for adjusting thespace filler over time to allow initial acceptance by the stomach andincreasing volume to get a right balance of weight loss and lack ofnausea and vomiting.
 20. The gastric space filler device of claim 1,wherein the safety element is an inflatable balloon made of abiodegradable material.
 21. The gastric space filler device of claim 20,wherein the biodegradable material is selected from a group consistingof polymers or copolymers of lactide, glycolide, caprolactone,polydioxanone, trimethylene carbonate, polyorthoesters, and polyethyleneoxide.
 22. The gastric space filler device of claim 20, wherein thebiodegradable material is selected from a group consisting of collagen,chitosan, elastin, gelatin, and combinations thereof.
 23. The gastricspace filler device of claim 1, wherein the space filler is made of anon-biodegradable material selected from a group consisting ofpolyester, polypropylene, Nylon, polyethylene, silicone, latex,polyethylene, and copolymers thereof.
 24. A gastric space filler devicefor treating obesity in a patient by reducing a stomach volumecomprising an inflatable space filler with a first reference shape at aninflated state and means for substantially maintaining said firstreference shape at a deflated state.
 25. The gastric space filler deviceof claim 24, wherein the means for substantially maintaining said firstreference shape at the deflated state is to provide a spiral supportiveridgeline onto said space filler.
 26. The gastric space filler device ofclaim 25, wherein the spiral ridgeline comprises a material similar tomaterial of the space filler.
 27. The gastric space filler device ofclaim 24, wherein the means for substantially maintaining said firstreference shape at the deflated state is to provide a plurality of crossbars inside an interior space of said space filler.
 28. A gastric spacefiller device for treating obesity in a patient by reducing a stomachvolume comprising an inflatable space filler with a firstcross-sectional circumference dimension at an inflated state and meansfor maintaining a second cross-sectional circumference dimension with atleast 75 percentage of said first circumference dimension at a deflatedstate.